May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

This Funding Opportunity Announcement (FOA) issued by the
National Institute on Aging (NIA), National Institutes of Health, invites
applications that propose basic, clinical, translational, epidemiological and
outcomes research on solid organ transplant (SOT) in older persons. Research
may focus on, but is not limited to 1) appropriate selection of older SOT donors
and recipients; 2) improved management of older SOT recipients; 3) immunology
and immunosuppression pertaining to older SOT patients; and 4) healthcare
disparities, utilization and costs of SOT in older patients. Research
supported by this initiative is expected to enhance knowledge of
immunobiology in aging and transplantation, and to provide evidence-based
guidance to improve access to transplantation, organ allocation and
utilization, graft survival, and short- and long-term outcomes of SOT in
older persons.

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.
Learn more.

Over the past decade, both the numbers of patients age 65
years and older referred for solid organ transplantation (SOT; kidney, liver,
heart or lung) and donating organs, has been increasing. As the proportion of
older individuals in the population expands, these trends will likely continue.
However, despite similarly favorable long-term outcomes in older and younger
SOT recipients, older patients are placed on the waiting list far less
frequently than younger patients. Once listed, the proportion of older compared
with younger SOT recipients is organ-specific, with the highest percentage of
lungs going to older recipients (due to higher idiopathic pulmonary fibrosis
incidence in seniors), followed by kidney (old and young roughly equal), while
livers and hearts are transplanted far less frequently in older patients. To
improve organ allocation and short- and long-term outcomes, and to better
understand the complexities of the SOT selection, management and compatibility
in the older host, specific research is needed.

Although seemingly beneficial, the increase in organs
donated from older adults currently has drawbacks, as older organs have a
higher rate of graft failure and worse outcomes than organs from younger
donors. Factors shown to impair function of older donated organs include long
harvest and ischemic time, organs from deceased versus live donors (kidney,
liver), comorbidities and chronic infections (cytomegalovirus) of the older
donor, and age-related decline in organ function. Accurate functional
assessment of potential donated organs remains limited, resulting in discard of
approximately 65% of donated kidneys and livers from donors 65 years or older.
Usage of expanded criteria donors (ECD) organs, which are often donated by
older individuals, may reduce this high discard rate, but target ECD recipient
criteria need further refinement. Development of age-specific screening and
assessment tools to evaluate older donors and their organ function and
viability may increase the number and outcomes of available organs for transplant.

Multiple factors complicate the selection of potential older
recipients for SOT that, in turn, further challenges organ allocation, which is
currently based on illness severity. Advanced age often limits organ transplant
referral, listing, and transplantation, yet chronologic age is likely a
surrogate for more specific outcome predictors including functional status vs.
frailty, comorbidities and/or body composition. Advanced criteria based on
these factors plus those common in older adults (chronic infection, cancer
risk, aging of other organs) require additional assessment for predictive
value. Equally important, the ability to predict outcomes focused on the
overall transplant goals for the older patient, such as improvement in physical
function/independence, health-related quality of life (HRQOL), cognitive
function and QOL on alternative palliation or end-stage therapies may provide
key insight into recipient selection and organ allocation in addition to those
which can predict graft survival.

Racial and ethnic disparities exist in both the
accessibility to and outcomes of transplantation. Despite a four-fold higher
incidence of end-stage renal disease in minorities, Hispanic patients are less
likely to receive SOT and African-Americans are less likely to be listed or
receive SOT compared with Caucasians. Regarding patient and graft long-term
survival, Asians and Hispanics have the most favorable outcomes followed by Caucasians,
then African-Americans for all transplanted organs. The factors contributing to
SOT access and outcome disparities between racial and ethnic groups are not
well characterized.

Numerous age-related alterations in the immune system occur
that may have important implications for the older transplant recipient.
Cell-mediated immunity is most affected by aging, with a decline in naïve T
cells and clonally expanded CD8 T cells resulting in less T cell diversity,
diminished host defense, and accumulated ‘exhausted’ and ‘senescent’ T cells
lacking CD28 expression. Accompanying these changes are increases in cytokine
production and chronic inflammation and diminished reliance on T cell co-stimulation.
These immune age-associated changes may be further altered by chronic host
viral infection such as cytomegalovirus. As acute graft rejection is more
profound and long-term graft failure is more common and more severe in older
recipients, the impact of aging altered immunobiology on immunosuppressive
therapy in older transplant patients requires further understanding.
Age-related changes in immunity also increase vulnerability of the older adult
to infections, which remain the most common cause of mortality in the first
year after transplant in the older patient. Research is needed to evaluate the
balancing of efficacy and toxicity of immunosuppressive therapy, and the
intensity and breadth of infectious prophylaxis and treatment, including
immunizations, in the older transplant recipient. Additionally, biologic
methods to assess immune function in the older SOT candidate and recipient might
assist these therapeutic decisions.

The management of older SOT recipients is complex and
requires a multidisciplinary approach. Multimorbidities, polypharmacy and
aging changes of other organ systems occur commonly in older patients, and may
be additionally compounded by cognitive or functional decline, osteoporosis and
glucose intolerance. Strategies to minimize or eliminate peri-operative and
post-operative vulnerabilities of older donors and recipients including
infections, delirium, pain and prolonged hospitalization need development. The
potential role of strength training and exercise prior to surgery, or
‘pre-hab’, and post-operative rehabilitation to improve outcomes in older SOT
donors and recipients requires further investigation. Additionally, elucidation
of mechanisms underlying the increased incidence of infections, acute rejection,
and malignancies in older compared to younger SOT recipients may guide
appropriate surveillance protocols. These important health aspects also deserve
attention in younger transplant patients as they age.

A workshop reviewing the current state of knowledge and
identifying research opportunities in solid organ (kidney, lung, liver and
heart) transplantation in older adults was held in Washington, D.C. in January
2012 and was sponsored by the NIA, NIDDK, NIAID, NHLBI, the American for
Academic Internal Medicine, the Hartford Foundation and the American Society of
Geriatrics. Key points of this workshop including an extensive list of proposed
research topics are summarized in Abecassis et al. American Journal of Transplantation 2012;12:2608-2622.

Scope of Research

The FOA invites research applications addressing the
selection of older solid organ transplant donors and recipients, the management
of older solid organ transplant patients, immunology and immunosuppression
pertaining to older transplant patients, and healthcare disparities,
utilization and cost of older transplant patients. Both animal models and human
subjects are appropriate for this FOA. Areas of interest include, but are not
limited to the following:

Selection
of Older Solid Organ Transplant Donors and Recipients

Identification of predictors of short- and long-term success of
older SOT recipients and development of risk evaluation tools; for example,
using specific predictors of outcomes for which chronologic age may be a
surrogate (e.g., physical function/frailty, cognitive function, body
composition, comorbidities, aging of non-transplanted organs/physiologic
reserve).

Incorporation of relevant outcomes for older transplant donors
and recipients (e.g., functional status, cognitive function, independence,
expected years to be gained, quality of life including health-related [HRQOL]).

Understanding impact of end-stage organ disease on comorbidities,
physiologic reserve, functional and cognitive status, and identification of
components that may be improved or reversed with transplantation.

Management
of Older Solid Organ Transplant Recipients

Strategies to reduce peri- and post-operative risk (e.g., acute
rejection, infection, pain and delirium) in older SOT donors and recipients,
such as through exercise/rehabilitation before and after surgery to improve
outcomes and preserve independence.

Understanding the impact and management of comorbidities,
increased cancer risk, and age-related physiologic changes (renal
insufficiency, arterial stiffness, bone demineralization, glucose intolerance)
in the older SOT recipient, the role of additional
monitoring/screening/prevention strategies, and management of SOT recipients as
they age.

Elucidation of age-related changes in innate and cellular
immunity (T and B cell function) on SOT acute and chronic rejection and
immunosuppression of the recipient; the importance of immune senescence,
immune-activating and immune inhibitory responses in older SOT recipients; and
biologic assays to assess immune function in older adults.

Understanding the impact of end-stage organ disease on immunity
in older patients, and roles of intrinsic (recipient) versus extrinsic (donor)
influences in an older immune system.

Understanding interactions among chronic infections (i.e. cytomegalovirus,
Epstein Barr), chronic inflammation, and alterations in immune function with
age in the setting of immunosuppression.

Identifying age-specific barriers to SOT referral, listing, and
transplantation for donors and recipients.

Understanding racial and ethnic disparities in referral, listing,
transplantation, or short and long-term outcomes in older SOT donors and
recipient, including variables such as communication, socioeconomic status,
risk/benefit education, and other biologic, behavioral, and social mechanisms,
and developing interventions to address these disparities.

Evaluation of long-term outcomes of SOT allocation to older
patients according to such measures as HRQOL, comparative efficacy, burden and
cost of alternative therapies, and quality-adjusted life-years.

The NIH R03 grant mechanism supports discrete, well-defined
projects that realistically can be completed in two years and that require
limited levels of funding. Preliminary data are not required, particularly in
applications proposing pilot or feasibility studies.

Specific age ranges for older patients or aged animals are
not specified for this FOA. Age ranges and groups should be selected to address
the study hypotheses and effectively utilize the demographic composition of
available patient groups, study cohorts, or data sets. Applications may address
changes across a span of ages as appropriate for the study questions, and
younger age groups may be included for comparison purposes.

Resources that may be useful for researchers developing
proposals for this FOA include longitudinal datasets designed for the study of
older populations, administrative datasets with medical information, and
datasets from large observational or intervention studies in specific diseases
or conditions. NIH-sponsored longitudinal aging cohorts that may be
particularly relevant for questions regarding immunity and aging include:

Health and Retirement Survey (HRS)

Baltimore Longitudinal Study on Aging (BLSA)

Lifestyle Intervention for Elders (LIFE) study

Cardiovascular Health Study (CHS)

Multi-Ethnic Study of Atherosclerosis (MESA)

Datasets may be augmented through data linkage or by
collection of additional information targeted toward specific study questions.
Potential study populations that focus on aging beyond those mentioned above are
listed in NIA's Population Studies Database (http://nihlibrary.ors.nih.gov/nia/ps/niadb.asp).
Large longitudinal and epidemiological studies that focus on factors related to
cognitive and emotional health/impairment in adults are listed in the NIH
Cognitive and Emotional Health Project database (http://trans.nih.gov/cehp/hbq/search.asp).

In addition, multiple organ transplant databases are
available for research opportunities including:

Scientific Registry of Transplant Recipients (SRTR-all organs)

International Society of Heart and Lung Transplantation Registry
(ISHLT)

Applicants studying human subjects are encouraged to use
standard assessment instruments and techniques that have been developed and
validated in older populations when possible, or may propose to test and
validate such new instruments. Applicants proposing studies on treatment
outcomes are encouraged to consider including measures of overall health
status, functional status, and quality of life, as well as specific measures
related to study hypotheses. A multidisciplinary research approach, including
expertise in nephrology/gastroenterology/pulmonary/cardiology, transplant
surgery, anesthesiology, immunology, infectious diseases, physiology, biology
of aging, neurobiology of aging, ethics, rehabilitation, psychiatry/psychology,
transplant nursing, and geriatrics is strongly encouraged.

Animal models may be used to address questions that cannot
be easily addressed in humans. The choice of the animal model should be
justified and its relevance to the study question should be explained clearly.
NIA's Scientific Resources, including the Nonhuman Primate Tissue Bank and
Rodent Resources, are described at http://www.nia.nih.gov/research/scientific-resources.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

The combined budget for direct costs for the two year
project period may not exceed $100,000. No more than $50,000 in direct costs
may be requested in any single year.

Award Project Period

The total project period may not exceed two years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete the following registrations
as described in the SF424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application
Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to
circumvent page limits. Follow all instructions for the Appendix as described
in the SF424 (R&R) Application Guide with the following modification:

No publication or other printed material, with the exception of
pre-printed questionnaires or surveys, may be included in the Appendix.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the deadline in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

The R03 small grant supports discrete, well-defined projects
that realistically can be completed in two years and that require limited
levels of funding. Because the research project usually is limited, an R03
grant application may not contain extensive detail or discussion. Accordingly,
reviewers should evaluate the conceptual framework and general approach to the
problem. Appropriate justification for the proposed work can be provided
through literature citations, data from other sources, or from
investigator-generated data. Preliminary data are not required, particularly in
applications proposing pilot or feasibility studies.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Council on Aging. The following will be
considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.